Actively Recruiting

Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID01246765

National Pregnancy Registry for Psychiatric Medications

Led by Massachusetts General Hospital · Updated on 2025-10-24

5000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

A

Alkermes, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety of various psychiatric medications taken during pregnancy, including antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics. The goal is to gather detailed information on whether these medications increase the risk of major birth defects or affect neonatal outcomes, as current data is limited. This observational study aims to better understand risks for infants exposed to psychiatric medications in the womb and maternal health outcomes associated with their use during pregnancy. Pregnant women taking these medications are grouped based on the type of psychiatric drug they have used, such as atypical antipsychotics, antidepressants, ADHD medications, sedative hypnotics, or other psychiatric medications. The study collects data prospectively and systematically throughout pregnancy and postpartum periods. Specific medications of interest include well-known brands like Abilify, Seroquel, Spravato, and Qelbree, among others. Participants provide information over the phone and consent to ongoing monitoring of pregnancy and infant health. Researchers assess major malformations in infants up to one year of age, tracked through medical records and postpartum interviews. They also evaluate various maternal and neonatal outcomes, including gestational weight gain, birth outcomes, neonatal complications, and child developmental assessments at multiple time points up to five years. The study lasts from pregnancy through early childhood follow-up, with detailed data collection at key intervals.

CONDITIONS

Brief Title

National Pregnancy Registry for Psychiatric Medications

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women
  • Age 18-45 years
  • Willingness to participate over the phone
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Women who have completed their pregnancy
  • Women planning to become pregnant
  • Women not taking psychiatric medications or without a history of psychiatric illness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (phone-based)

Monitoring

Duration - Pregnancy duration until birth

Participants are observed throughout their pregnancy to document medication exposure and maternal and neonatal outcomes.

Periodic phone assessments during pregnancy

Postpartum Follow-up

Duration - Up to 1 year after birth

Participants and their infants are followed after birth to assess infant health, development, and maternal outcomes.

Multiple phone or medical record assessments at 8-12 weeks postpartum and at 9 months, 3 years, and 5 years for child development

Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

B

Bryn Rediger

L

Lee Cohen, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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Published Research Related To This Trial

Reproductive Safety of Second-Generation Antipsychotics: Current Data From the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics.

Lee S Cohen, Adele C Viguera, Kathryn A McInerney...

https://pubmed.ncbi.nlm.nih.gov/26441156

Effects of Prenatal Exposure to Second-Generation Antipsychotics on Development and Behavior Among Preschool-Aged Children: Preliminary Results From the National Pregnancy Registry for Psychiatric Medications.

Carol Swetlik, Lee S Cohen, Lauren A Kobylski...

https://pubmed.ncbi.nlm.nih.gov/38488388

Risk of Major Malformations in Infants After First-Trimester Exposure to Stimulants: Results From the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications.

Mercedes J Szpunar, Marlene P Freeman, Lauren A Kobylski...

https://pubmed.ncbi.nlm.nih.gov/37235505

Risk of Major Malformations Following First-Trimester Exposure to Olanzapine: Preliminary Data From the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications.

Adele C Viguera, Marlene P Freeman, Lauren A Kobylski...

https://pubmed.ncbi.nlm.nih.gov/36825887

Reproductive Safety of Lurasidone and Quetiapine: Update from the National Pregnancy Registry for Psychiatric Medications.

Lee S Cohen, Taylor R Church, Marlene P Freeman...

https://pubmed.ncbi.nlm.nih.gov/36716275

Risk of Poor Neonatal Adaptation Syndrome Among Infants Exposed to Second-Generation Atypical Antipsychotics Compared to Antidepressants: Results From the National Pregnancy Registry for Psychiatric Medications.

Adele C Viguera, Sara A McElheny, Phoebe S Caplin...

https://pubmed.ncbi.nlm.nih.gov/36602927

Risk of major malformations in infants after first-trimester exposure to benzodiazepines: Results from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications.

Mercedes J Szpunar, Marlene P Freeman, Lauren A Kobylski...

https://pubmed.ncbi.nlm.nih.gov/35909254

Reproductive Safety of Second-Generation Antipsychotics: Updated Data From the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics.

Adele C Viguera, Marlene P Freeman, Lina Góez-Mogollón...

https://pubmed.ncbi.nlm.nih.gov/34352165

Reproductive safety of aripiprazole: data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics.

Marlene P Freeman, Adele C Viguera, Lina Góez-Mogollón...

https://pubmed.ncbi.nlm.nih.gov/33710399